The present invention relates to the field of angioplasty. In particular, the present invention is a Y-adaptor manifold assembly having passive hemostatic valve mechanisms.
Angioplasty has gained wide acceptance in recent years as an efficient and effective method for treating various types of vascular diseases. In particular, angioplasty is widely used for opening stenoses in the coronary arteries, although it is also used for treatment of stenoses in other parts of the vascular system.
The most widely used form of angioplasty makes use of a guide catheter positioned within the vascular system of a patient. The distal end of the guide catheter is inserted into the femoral artery located in the groin of the patient and pushed distally up through the vascular system until the distal end of the guide catheter is located in the ostium of the coronary artery. The distal end of the guide catheter is normally curved so that the distal tip of the guide catheter is more easily directed to the coronary ostium of the patient. Typically, a Y-adaptor manifold assembly 10 such as shown in prior art FIG. 1 is releasably secured to the proximal end of the guide catheter. The proximal end of the guide catheter and the manifold assembly 10 protrude outside the patient's body. The manifold assembly 10 provides an entryway for subsequent insertion of additional angioplasty devices into the patient's vascular system through the guide catheter. The additional angioplasty devices include dilatation catheters such as non-over-the-wire and over-the-wire balloon catheters.
The prior art Y-adaptor manifold assembly 10 shown in FIG. 1 typically includes a main body portion 12 that is secured at its distal end to the guide catheter via a luer fitting 14. The manifold assembly 10 further includes a first side branch 16 that defines an infusion port, and a second side branch 18 that is configured to receive a dilatation balloon catheter. The main body portion 12 of the manifold assembly 10 is likewise configured to receive a dilatation balloon catheter. The second side branch 18 and main body portion 12 allow two balloon catheters to be inserted into a patients' arteries so that plural stenoses can be dilated at the same time. Typically, a longitudinal axis 15 of the second side branch 18 forms an angle of thirty degrees or forty-five degrees with respect to a longitudinal axis 17 of the main body portion 12.
Proximal ends of the second side branch 18 and the main body portion 12 include valves known as Tuohy-Borst seals 20 that minimize backbleeding. Each Tuohy-Borst seal 20 includes a gasket 22 having a through aperture 24 and a threadably attached cap 26. The through aperture 24 is configured to receive a shaft of the dilatation catheter. The cap 26 can be rotatably tightened to compress the gasket 22 thereby decreasing the diameter of the through aperture 24 to form a fluid tight seal about the shaft of the dilatation catheter. However, if the cap 26 of the Tuohy-Borst seal 20 is tightened too much, the dilatation catheter may be damaged or the flow of inflation fluid through the catheter may be restricted so as to make inflation of the balloon of the dilatation catheter difficult. On the other hand, tightening the cap 26 too little may allow backbleeding through the proximal ends of the second side branch 18 and the main body portion 12 of the manifold assembly 10.
There is a continuing need for improved Y-adaptor manifold assemblies. Specifically, there is a need for a manifold assembly of efficient design which incorporates a valve member that provides an effective releasable seal about the shaft of a dilatation catheter. The valve member would provide a fluid tight seal about the dilatation catheter to prevent backbleeding, while minimizing damage to the catheter. In addition, the seal formed by the vale member would not restrict the flow of inflation fluid through the dilatation catheter.